This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.
This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.
Study Type
OBSERVATIONAL
Enrollment
118
Mount Sinai Hospital
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
The Cancer Institute At Alexian Brothers
Elk Grove Village, Illinois, United States
Northwest Oncology & Hematology, SC
Hoffman Estates, Illinois, United States
Hematology/Oncology Of The North Shore
Lake Forest, Illinois, United States
Northwest Oncology & Hematology, SC
Rolling Meadows, Illinois, United States
Healthcare Research Network III, LLC
Tinley Park, Illinois, United States
American Health Network
Avon, Indiana, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Hazard Arh Regional Medical Center
Hazard, Kentucky, United States
...and 14 more locations
changes in cardiovascular risk from baseline using the Framingham Coronary Heart Disease Score
Time frame: up to 24 months
changes in metabolic risk from baseline using metabolic lab values
Time frame: up to 24 months
echocardiography to assess left ventricular function
Time frame: up to 24 months
urinary protein excretion to assess early vascular endothelial changes
Time frame: up to 24 months
coronary calcium scoring to assess coronary artery narrowing
Time frame: up to 24 months
metabolic labs (Plasma Glucose, HbA1c, Fasting Lipids) for assessing the metabolic disease
Time frame: up to 24 months
safety and tolerability of first-line BCR-ABL TKIs in adults with CP-CML based on the number of treatment-related adverse events collected in the medical records
Time frame: up to 24 months
clinical outcomes as described by the number of deaths from clinical assessments of disease status and mutational analysis
Time frame: up to 24 months
clinical outcomes as described by the major molecular response from clinical assessments of disease status and mutational analysis
Time frame: up to 24 months
clinical outcomes as described by the cytogenetic response from clinical assessments of disease status and mutational analysis
Time frame: up to 24 months
time to development of clinical outcomes from baseline to time of clinical outcome event based on clinical assessments
Time frame: up to 24 months
description of treatment patterns based on the number of changes in treatment dosing, interruptions, changes in therapy, duration of therapy and treatment discontinuations through the management of adverse events and comorbid disease
Time frame: up to 24 months
description of the demographic and clinical patient characteristics associated with initial treatment choice and changes of treatment based on the medical records
Time frame: up to 24 months
measurement of serum biomarkers that are predictive of an increased risk for cardiovascular or metabolic disease
Time frame: up to 24 months
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